Amyotrophic Lateral SclerosisARCNCT06885918
ALS Research Collaborative
An observational study of Amyotrophic Lateral Sclerosis and ALS (Amyotrophic Lateral Sclerosis), run by ALS Therapy Development Institute at 1 site in United States.
Trial summary
The goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (ALS). This study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, ALS (Amyotrophic Lateral Sclerosis), ALS With Frontotemporal Dementia (ALS/FTD)
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2014to 31 Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants can be located anywhere but require internet access.
Who may be able to join
- 18 years of age or older
- Can communicate in written English
- Has a diagnosis of ALS/MND or is a known carrier of an ALS associated mutation
Who cannot join
- Significant cognitive impairment that would prevent individual completion and understanding of the informed consent process.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
ALS Therapy Development Institute
Watertown, Massachusetts, 02472
Alan S Premasiri, M.S., 6174417200 ext. 7291, apremasiri@als.net
Fernando G Vieira, M.D.
About this study
Official title: ALS Translational Research Program
The goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (ALS). This study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. Adults living with ALS, other motor neuron diseases (MND), a known mutation related to ALS and healthy volunteers contribute prospective and retrospective data to this study remotely. The study is sponsored and conducted by the ALS Therapy Development Institute.
- Conditions
- Amyotrophic Lateral Sclerosis, ALS (Amyotrophic Lateral Sclerosis), ALS With Frontotemporal Dementia (ALS/FTD), Motor Neuron Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis
- Keywords
- ARC, ALS Research Collaborative, ALS TDI, ALS Therapy Develeopment Institute
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Motor Neuron Disease, AIDS-Related Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Person living with ALS/MND | An adult over the age of 18, that has received a diagnosis of ALS or other Motor Neuron Disease from a practicing physician. | |
| Asymptomatic gene carrier | An adult over the age of 18 who does not have symptoms of ALS and carries a mutation known to be associated with ALS | |
| Healthy Volunteer | An adult over the age of 18 who does not have any biological connection to ALS or other Motor Neuron Disease, and no significant health problems. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALS Functional Rating Scale - Revised (ALSFRS-R)
A questionnaire completed by the participant that assesses 12 daily functions of living on a 0 (severe symptoms) to 4 (minimal to no symptoms) integer scale.
Measured: Monthly, through study completion, an average of 1 year
Secondary outcomes (4)
Machine-Learning Based Speech Scoring
Participants submit a scripted voice recording of 5 different, short phrases that are then scored by a machine-learning based algorithm that assess dysarthria on a non-integer scale of 0 (fully impaired) to 4 (normal speech)
Measured: Monthly, through study completion, an average of 1 year
Limb-based Accelerometry
Participants wear four, ActiGraph devices on each limb. Passive and active (video-directed) wear time data is collected over one week. The devices measure acceleration and represent the strength of each limb during movement. Outputs include activity counts and raw acceleration data.
Measured: monthly, through study completion, an average of 6 months
Medications, Supplements, and Clinical Trial Participation Surveys
Participants complete questionnaires describing usage information about medications and supplements they have taken and are currently taking, as well as clinical trial participation.
Measured: quarterly, through study completion, an average of 1 year
Social and Environmental Surveys
Participants complete questionnaires about their familial, educational, and geographical background, as well as lifestyle habits and past medical conditions and injuries. These are non-current factors that may have an affect on current health outcomes.
Measured: One-time or quarterly at months 1, 4, 7, 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start12 Sep 2014
- Primary completion31 Jan 2035 (estimated)
- Study completion31 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALS Therapy Development Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando G Vieira, M.D., Principal investigator, ALS Therapy Development Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06885918
- Sponsor's protocol ID
- ALSTDI0103
- Acronym
- ARC
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Straczkiewicz M, Burke KM, Calcagno N, Premasiri A, Vieira FG, Onnela JP, Berry JD. Free-living monitoring of ALS progression in upper limbs using wearable accelerometers. J Neuroeng Rehabil. 2024 Dec 21;21(1):223. doi: 10.1186/s12984-024-01514-7.
PubMed 39707523Gupta AS, Patel S, Premasiri A, Vieira F. At-home wearables and machine learning sensitively capture disease progression in amyotrophic lateral sclerosis. Nat Commun. 2023 Aug 21;14(1):5080. doi: 10.1038/s41467-023-40917-3.
PubMed 37604821Vieira FG, Venugopalan S, Premasiri AS, McNally M, Jansen A, McCloskey K, Brenner MP, Perrin S. A machine-learning based objective measure for ALS disease severity. NPJ Digit Med. 2022 Apr 8;5(1):45. doi: 10.1038/s41746-022-00588-8.
PubMed 35396385
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALS Translational Research Program
- ClinicalTrials.gov ID
- NCT06885918
- Acronym / sponsor ID
- ARC / ALSTDI0103
- Conditions
- Amyotrophic Lateral Sclerosis, ALS (Amyotrophic Lateral Sclerosis), ALS With Frontotemporal Dementia (ALS/FTD), Motor Neuron Disease, Motor Neuron Disease, Amyotrophic Lateral Sclerosis
- Keywords
- ARC, ALS Research Collaborative, ALS TDI, ALS Therapy Develeopment Institute
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- ALS Therapy Development InstituteUniversity, hospital or other
- Study start
- 12 Sep 2014 (actual)
- Primary completion
- 31 Jan 2035 (estimated)
- Study completion
- 31 Jan 2035 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this natural history study is to learn more about the biological and clinical aspects of amyotrophic lateral sclerosis (ALS). This study's findings will help with drug discovery, biomarker discovery, and outcome measure validation. Adults living with ALS, other motor neuron diseases (MND), a known mutation related to ALS and healthy volunteers contribute prospective and retrospective data to this study remotely. The study is sponsored and conducted by the ALS Therapy Development Institute.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Person living with ALS/MND | – | –An adult over the age of 18, that has received a diagnosis of ALS or other Motor Neuron Disease from a practicing physician. |
| Asymptomatic gene carrier | – | –An adult over the age of 18 who does not have symptoms of ALS and carries a mutation known to be associated with ALS |
| Healthy Volunteer | – | –An adult over the age of 18 who does not have any biological connection to ALS or other Motor Neuron Disease, and no significant health problems. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants can be located anywhere but require internet access.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Can communicate in written English
- Has a diagnosis of ALS/MND or is a known carrier of an ALS associated mutation
Key exclusion criteria (1 listed)
- Significant cognitive impairment that would prevent individual completion and understanding of the informed consent process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ALS Functional Rating Scale - Revised (ALSFRS-R)
Time frame: Monthly, through study completion, an average of 1 year
A questionnaire completed by the participant that assesses 12 daily functions of living on a 0 (severe symptoms) to 4 (minimal to no symptoms) integer scale.
4 secondary outcomes
Machine-Learning Based Speech Scoring
Time frame: Monthly, through study completion, an average of 1 year
Limb-based Accelerometry
Time frame: monthly, through study completion, an average of 6 months
Medications, Supplements, and Clinical Trial Participation Surveys
Time frame: quarterly, through study completion, an average of 1 year
Social and Environmental Surveys
Time frame: One-time or quarterly at months 1, 4, 7, 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Results publication: PubMed 39707523Straczkiewicz M, Burke KM, Calcagno N, Premasiri A, Vieira FG, Onnela JP, Berry JD. Free-living monitoring of ALS progression in upper limbs using wearable accelerometers. J Neuroeng Rehabil. 2024 Dec 21;21(1):223. doi: 10.1186/s12984-024-01514-7.
- Results publication: PubMed 37604821Gupta AS, Patel S, Premasiri A, Vieira F. At-home wearables and machine learning sensitively capture disease progression in amyotrophic lateral sclerosis. Nat Commun. 2023 Aug 21;14(1):5080. doi: 10.1038/s41467-023-40917-3.
- Results publication: PubMed 35396385Vieira FG, Venugopalan S, Premasiri AS, McNally M, Jansen A, McCloskey K, Brenner MP, Perrin S. A machine-learning based objective measure for ALS disease severity. NPJ Digit Med. 2022 Apr 8;5(1):45. doi: 10.1038/s41746-022-00588-8.
- ARC Sign Up PageLink provided by the sponsor.
- ARC Data Commons Inquiry Page - for researcher access to ARC dataLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fernando G Vieira, M.D. principal investigator
ALS Therapy Development Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyotrophic Lateral Sclerosis and ALS (Amyotrophic Lateral Sclerosis), run by ALS Therapy Development Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alan S Premasiri, M.S. (617-441-7200 ext. 7291, apremasiri@als.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ALS Functional Rating Scale - Revised (ALSFRS-R) (time frame: Monthly, through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06885918, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.